Last update: July 31, 2018

Pimecrolimus

Very Low Risk for breastfeeding


Safe. Compatible.
Not risky for breastfeeding or infant.

An immunomodulator and calcineurin inhibitor related to tacrolimus. Used in the treatment of atopic dermatitis.
Used topically as a cream and orally in research studies.

Since the last update we have not found published data on its excretion in breastmilk.

Its pharmacokinetic data (moderately high molecular weight, high percentage of protein binding and very little systemic absorption with topical use (less than 2 micrograms/L in plasma) (AEMPS 2013, FDA 2001) make it unlikely that will be transferred to milk in significant quantities (AEMPS 2013).

Do not apply on the breast in order to prevent the infant from swallowing it (AEMPS 2013, Barret 2013, Butler 2014); if necessary, apply after a feed and clean well with water before the next feed.

It is advisable to avoid the application of creams, gels and other local application products containing paraffin (mineral oil) on the nipple so that the infant does not absorb them (Noti 2003, Concin 2008).

Alternatives

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Pimecrolimus in other languages or writings:

Group

Pimecrolimus belongs to this group or family:

Tradenames

Main tradenames from several countries containing Pimecrolimus in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. Dermat: baja - poor %
Molecular weight 811 daltons
Protein Binding 74 - 99,6 %
Tmax 2 hours
T1/2 100 hours

References

  1. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014 Mar;70(3):417.e1-10; quiz 427. Abstract
  2. AEMPS. Pimecrolimus. Ficha técnica. 2013 Full text (in our servers)
  3. Barrett ME, Heller MM, Fullerton Stone H, Murase JE. Dermatoses of the breast in lactation. Dermatol Ther. 2013 Abstract
  4. Concin N, Hofstetter G, Plattner B, Tomovski C, Fiselier K, Gerritzen K, Fessler S, Windbichler G, Zeimet A, Ulmer H, Siegl H, Rieger K, Concin H, Grob K. Mineral oil paraffins in human body fat and milk. Food Chem Toxicol. 2008 Abstract
  5. Noti A, Grob K, Biedermann M, Deiss U, Brüschweiler BJ. Exposure of babies to C15-C45 mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003 Abstract
  6. Scott G, Osborne SA, Greig G, Hartmann S, Ebelin ME, Burtin P, Rappersberger K, Komar M, Wolff K. Pharmacokinetics of pimecrolimus, a novel nonsteroid anti-inflammatory drug, after single and multiple oral administration. Clin Pharmacokinet. 2003 Abstract
  7. FDA. Pimecrolimus. Drug Summary. 2001 Full text (in our servers)

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